BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3200284 · Received July 1, 2013

    Report

    Report Number
    2953200-2013-01225
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION, EMBOLI); RELATED TO OPERATIONAL CONTEXT (LIMB OCCLUSION LIKELY DUE TO PLACEMENT OF BIFURCATE WITHIN THE PREVIOUSLY IMPLANTED 10MM LIMB DURING EMERGENT CASE); (CAUSE OF RENAL ARTERY OCCLUSION IS UNKNOWN). CONCLUSION: INHERENT RISK OF A PROCEDURE (OCCLUSION, EMBOLI); (CAUSE OF RENAL ARTERY OCCLUSION IS UNKNOWN); USER ERROR CONTRIBUTED TO EVENT (LIMB OCCLUSION LIKELY DUE TO PLACEMENT OF BIFURCATE WITHIN THE PREVIOUSLY IMPLANTED 10MM LIMB DURING EMERGENT CASE).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY IS UNKNOWN. THE PATIENT CAME IN EMERGENTLY FOR THE INDEX PROCEDURE, UPON THE ORIGINAL IMPLANT A 10X10X82 WAS PLACED FIRST AND THE MAIN BODY WAS TELESCOPED THROUGH THE 10X10X82. IT WAS REPORTED BY THE PHYSICIAN THAT ON A FOLLOW UP APPOINTMENT LAST WEEK IT WAS NOTED THAT HER LIMB WENT DOWN. THE CT SCAN FROM A PREVIOUS FOLLOW UP APPOINTMENT WAS REVIEWED AND EVERYTHING LOOKED FINE; HOWEVER, THE LEFT RENAL WAS OCCLUDED. SINCE THE AAA REPAIR THE PATIENT HAD A LEFT RENAL STENT PLACEMENT WHICH HAS OCCLUDED. THE STENT GRAFT WAS NOT COVERING THE LEFT RENAL. A RENAL STENT WAS PLACED POST PROCEDURE FOR EMBOLIC EVENTS FROM THE AAA PROCEDURE. IT IS UNKNOWN IF THE AAA PROCEDURE CAUSED THE RENAL TO GO DOWN OR THE RENAL STENT CAUSED THE RENAL TO GO DOWN. THE PHYSICIAN STATED THAT HE PLACED THE STENT POST PROCEDURE. THE PATIENT WENT HOME THE SAME DAY AND THE CAME BACK IN A FEW DAYS LATER AND WAS DOING FINE. THE 16 LIMB IN THE 10 LIMB CAUSED THE PROBLEM. THIS WAS DONE BECAUSE THE CASE WAS EMERGENT. THIS IS THE AREA THE BALLOON EXPANDABLE STENT WAS PLACED. BOTH LIMBS WERE OPEN; HOWEVER THERE WAS A SMALL AMOUNT OF THROMBUS IN THE RIGHT LIMB. THE PATIENT WAS SCHEDULED FOR AN ARTERIOGRAM AND A SECONDARY INTERVENTION. THE PHYSICIAN STARTED FROM THE RIGHT GROIN AND PLACED A SHEATH IN, THE PHYSICIAN WAS ABLE TO PASS A WIRE UP THE OCCLUDED LIMB. THE PHYSICIAN STARTED TPA THROUGH THE ANGIOJET CATHETER AND WAITED 20 MINUTES FOR THE TPA TO WORK. AFTER 20 MINUTES A MARKER PIG CATHETER WAS PLACED AND THE LIMB WAS OPEN WITH SOME THROMBUS AROUND THE FLOW DIVIDER. A 14MM ANGIOPLASTY BALLOON WAS INFLATED TO PROFILE. AFTER THE PTA ANOTHER MANUFACTURER¿S 10X57 BALLOON EXPANDABLE STENT WAS IMPLANTED IN THE LIMB AROUND THE TRANSITION. THE POST ANGIOGRAM SHOWED MINIMAL AMOUNT OF THROMBUS IN THE FLOW DIVIDER. THE PHYSICIAN WAS VERY HAPPY WITH THE RESULT AND THE PROCEDURE WAS COMPLETE. THE PHYSICIAN DID A RIGHT LEG ANGIOGRAM TO MAKE SURE NO CLOT WAS SHOWERED TO THE DISTAL LEG VESSELS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300091 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00987884

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention